BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 5899673 · Received August 24, 2016

    Report

    Report Number
    8030965-2016-14633
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Report Date
    July 22, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. HOWEVER, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE COUPLING POWER SUPPLY WAS DEFORMED, BENT AND THE COUPLING SHAFT WAS BROKEN ON THE COMPACT AIR DRIVE DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRE-TESTS: GENERAL CONDITION, CHECK THE ATTACHMENT COUPLING, CHECK ATTACHMENT COUPLING WITH ATTACHMENTS, CHECK REVERSE LOCKING MECHANISM, CHECK AIR HOSE COUPLING, CHECK FOR AIR LEAK, CHECK FUNCTION OF SOFT MODE SWITCH (SAFETY SYSTEM), CHECK FOR UNTRUE RUNNING, CHECK FOR EXCESSIVE NOISE, CHECK THE POWER WITH TEST BENCH AND CHECK STARTING BEHAVIOR. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS BLOCKED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551206 CAD II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1